Integrated automatic blood collection and processing unit
First Claim
Patent Images
1. A centrifuge for use in the continuous separation of blood into components comprising:
- a housing;
a disk structure rotatably mounted within the housing;
said disk structure forming a separation channel comprising an inner wall and an outer wall;
a first input port adapted for introducing whole blood into the separation channel;
a first output port adapted for removing concentrated red blood cells from the separation channel; and
a second output port adapted for removing plasma from the separation channel;
said separation channel substantially defining a circle having a centerpoint and a circumference;
wherein said disk structure is adapted for mechanical connection to a motor for rotating the disk structure about a central axis such that the circle defined by the separation channel is perpendicular to the central axis and the centerpoint is substantially aligned with the central axis;
and wherein the separation channel has a first portion where the outer wall is at or near its maximum distance from the central axis and wherein the first output port is positioned in the first portion of the separation channel.
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Abstract
A system for automatically collecting and separating whole blood into its components is described. The system includes a console, which contains all motors, pumps, sensors, valves and control circuitry, and a unique disposable set that includes a cassette supporting a centrifuge with an improved design, pump interfaces with an improved design, component and solution bags, and tubing. Various processes are implemented using a specific disposable set for each process which allows automatic identification of the process to be performed the console.
170 Citations
79 Claims
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1. A centrifuge for use in the continuous separation of blood into components comprising:
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a housing;
a disk structure rotatably mounted within the housing;
said disk structure forming a separation channel comprising an inner wall and an outer wall;
a first input port adapted for introducing whole blood into the separation channel;
a first output port adapted for removing concentrated red blood cells from the separation channel; and
a second output port adapted for removing plasma from the separation channel;
said separation channel substantially defining a circle having a centerpoint and a circumference;
wherein said disk structure is adapted for mechanical connection to a motor for rotating the disk structure about a central axis such that the circle defined by the separation channel is perpendicular to the central axis and the centerpoint is substantially aligned with the central axis;
and wherein the separation channel has a first portion where the outer wall is at or near its maximum distance from the central axis and wherein the first output port is positioned in the first portion of the separation channel. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 76, 77, 78)
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24. A method of simultaneous blood collection and separation using a continuous flow centrifuge having a separation channel, a blood input port, a concentrated red blood cell output port and a first plasma output port, comprising the steps of:
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collecting blood from a donor to form a blood flow;
simultaneously with the collecting step adding an anticoagulant to the blood flow to form an anticoagulated blood flow;
simultaneously with the adding step, introducing the anticoagulated blood flow into the separation channel through the blood input port while keeping the blood input port open;
simultaneously with the introducing step, operating the centrifuge to produce a flow of concentrated red blood cells and a flow of plasma from the anticoagulated blood flow;
simultaneously with the operating step, directing the flow of plasma from the separation channel through the first plasma output port into a plasma collection bag while keeping the first plasma output port open;
simultaneously with the operating step, directing the flow of concentrated red blood cells from the separation channel through the red blood cell output port into a fluid transportation means while keeping the red blood cell output port open;
simultaneously with the operating step, introducing red cell storage solution into the flow of concentrated red blood cells in the fluid transportation means;
simultaneously with the operating step, directing the flow of concentrated red blood cells from the fluid transportation means into a red blood cell collection bag. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59)
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60. A centrifuge for the continuous separation of blood comprising:
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a fixed bucket housing having a opening circumference;
a molded distributor mounted in the housing so as to inhibit rotation of the molded distributor relative to the housing, comprising a first duct having a first end and a second end;
a second duct a first end and a second end and a third duct a first end and a second end, and wherein the first end of the first duct is adapted for connection to a first component external to the centrifuge;
the first end of the second duct is adapted for connection to a second component external to the centrifuge; and
the first end of the third duct is adapted for connection to a third component external to the centrifuge;
a stationary seal member mounted in the housing, said stationary seal member forming a first central hole providing communication through the stationary seal member to the second end of the first duct; and
further forming a first annular groove and a first access hole within the first annular groove providing communication through the stationary seal member between the first annular groove and the second end of the second duct; and
further forming a second annular groove and a second access hole within the second annular groove providing communication through the stationary seal member between the second annular groove and the second end of the third duct;
a disk cap comprising a mounting ring rotably mounted on the opening circumference of the housing, said disk cap forming a first hole, a second hole and a third hole;
a disk mounted on the disk cap;
said disk forming a separation channel substantially defining a circle, said disk adapted for mechanical connection to a motor for rotating the disk, disk cap and rotating seal member about a central axis such that the circle defined by the separation channel is perpendicular to the central axis;
a first fluid transport means communicating between the separation channel and the first hole in the disk cap;
a second fluid transport means communicating between the separation channel and the second hole in the disk cap;
a third fluid transport means communicating between the separation channel and the second hole in the disk cap;
a rotating seal member mounted on the disk structure, said rotating seal member forming a second central hole aligned with the first central hole, said second central hole also aligned with the first hole in the disk cap and providing communication through the rotating seal member to the first hole in the disk cap;
said rotating seal structure further forming a third annular groove aligned with the first annular groove and a third access hole within the third annular groove aligned with the second hole in the disk cap and providing communication through the rotating seal member between the third annular groove and the second hole in the disk cap;
said rotating seal further forming a fourth annular groove aligned with the second annular grove and a fourth access hole within the fourth annular groove aligned with the third hole in the disk cap and providing communication through the rotating seal member between the fourth annular groove to the third hole in the disk cap. - View Dependent Claims (61, 62, 63)
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64. The centrifuge of claim 60 wherein the first end of the first duct is adapted for connection to a source of whole blood;
- the first end of the second duct is adapted for connection to a bag for storing concentrated red blood cells and the first end of the third duct is adapted for connection to a bag for storing plasma.
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64-1. A cassette adapted for mounting on a console, wherein the console includes a first motor and pump rotors driven by a second motor;
- comprising;
a frame;
a continuous flow centrifuge supported on the frame, said continuous flow centrifuge comprising;
a housing;
a rotor rotably supported in the housing, adapted to be driven by the first motor when the cassette is mounted on the console;
a disk, mounted to the rotor;
wherein the rotor is supported in a horizontal position relative to the console when the cassette is mounted on the console;
said continuous flow centrifuge having an input port adapted to receive and hold a first length of flexible tubing for delivering fluid to the disk and an output port adapted to receive and hold a second length of flexible tubing for removing fluid from the disk;
a manifold supported on the frame, said manifold comprising;
a first tube receptacle, a second tube receptacle, third tube receptacle and a fourth tube receptacle, each of the tube receptacles adapted to receive and hold a length of flexible tubing;
a first pump tube segment defining a first end and a second end;
a second pump tube defining a first end and a second end;
a first fluid pathway, a second fluid pathway, a third fluid pathway and a fourth fluid pathway, wherein the pump tube segments, the flexible tubing and the fluid pathways are adapted to contain fluid; and
wherein the first tube receptacle is connected to the first end of the first pump tube segment by a first fluid pathway;
the second end of the first pump tube segment is connected to the second tube receptacle by a second fluid pathway; and
the third tube receptacle is connected to the first end of the second pump tube segment by a third fluid pathway, and the second end of the second tube segment is connected to the fourth tube receptacle by a fourth fluid pathway;
and wherein, the first length of flexible tubing connects the input port of the continuous flow centrifuge to the second tube receptacle, and the second length of flexible tubing connects the output port of the continuous flow centrifuge to the third tube receptacle;
and each of the pump tube segments is adapted for interface with a separate pump rotor when the cassette is mounted on the console, whereby fluid in the pump tube segment tube may be forced from the pump tube segment to a selected one of the fluid pathways.
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- 66. The cassette of claim 65 wherein at least one of the fluid pathways further includes a valve interface adapted for interaction with a valve contained in the console, when the cassette is mounted on the console, whereby the valve may selectively cause the pathway to be blocked.
- 68. The cassette of claim 65 wherein at least one of the fluid pathways further includes a pressure sensor interface, adapted to respond to a change in pressure in the fluid in the pathway, and further adapted for interaction with a pressure sensor contained in the console, when the cassette is mounted on the console, whereby an electronic signal may be produced by the pressure sensor in response to the change in pressure.
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72. The cassette of claim 65 wherein the cassette forms at least one hole, adapted, when the cassette is mounted on the console, to align with an ultrasonic sensor contained in the console, and a portion of the first length of flexible tubing is held in a fixed position to lie across the hole.
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73. The cassette of claim 65 further comprising a bag for containing fluid connected to the first tube receptacle by a third length of flexible tubing.
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74. An integrated system for simultaneously collecting and separating whole blood comprising:
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a console comprising a first motor and pump rotors driven by a second motor;
a cassette adapted for mounting on the console, said cassette comprising;
a frame;
a continuous flow centrifuge supported on the frame, said continuous flow centrifuge comprising;
a housing;
a rotor rotably supported in the housing, adapted to be driven by the first motor when the cassette is mounted on the console;
a disk, mounted to the rotor;
wherein the rotor is supported in a horizontal position relative to the console when the cassette is mounted on the console;
said continuous flow centrifuge having an input port adapted to receive and hold a first length of flexible tubing for delivering fluid to the disk and an output port adapted to receive and hold a second length of flexible tubing for removing fluid from the disk;
a manifold supported on the frame, said manifold comprising;
a first tube receptacle, a second tube receptacle, third tube receptacle and a fourth tube receptacle, each of the tube receptacles adapted to receive and hold a length of flexible tubing;
a first pump tube segment defining a first end and a second end;
a second pump tube defining a first end and a second end;
a first fluid pathway, a second fluid pathway, a third fluid pathway and a fourth fluid pathway, wherein the pump tube segments, the flexible tubing and the fluid pathways are adapted to contain fluid; and
wherein the first tube receptacle is connected to the first end of the first pump tube segment by a first fluid pathway;
the second end of the first pump tube segment is connected to the second tube receptacle by a second fluid pathway; and
the third tube receptacle is connected to the first end of the second pump tube segment by a third fluid pathway, and the second end of the second tube segment is connected to the fourth tube receptacle by a fourth fluid pathway;
and wherein, the first length of flexible tubing connects the input port of the continuous flow centrifuge to the second tube receptacle, and the second length of flexible tubing connects the output port of the continuous flow centrifuge to the third tube receptacle;
and each of the pump tube segments is adapted for interface with a separate pump rotor when the cassette is mounted on the console, whereby fluid in the pump tube segment tube may be forced from the pump tube segment to a selected one of the fluid pathways.
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75. The system of claim 65 further comprising a centrifuge mounted on the cassette, said centrifuge comprising:
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a housing;
a disk structure rotably mounted within the housing;
said disk structure forming a separation channel comprising an inner wall and an outer wall;
a first input port adapted for introducing whole blood into the separation channel;
a first output port adapted for removing concentrated red blood cells from the separation channel; and
a second output port adapted for removing plasma from the separation channel;
said separation channel substantially defining a circle having a centerpoint and a circumference;
wherein said console includes a disk drive motor, and said disk structure is adapted for a mechanical connection to the disk drive motor for rotating the disk structure about a central axis such that the circle defined by the separation channel is perpendicular to the central axis and the centerpoint is substantially aligned with the central axis;
and wherein the separation channel has a first portion where the outer wall is at or near its maximum distance from the central axis and wherein the first output port is positioned in the first portion of the separation channel. - View Dependent Claims (79)
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Specification